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Vytorin Probe Seeks More Information

Feb 20, 2009 | Parker Waichman Alonso LLP

Lawmakers investigating the cholesterol drug Vytorin have asked Merck and Schering-Plough for more information on the medication's clinical trials.  According to Reuters, Rep. Henry Waxman (D-Calif), chairman of the House Energy and Commerce Committee, has written two companies on Thursday seeking additional information about some Vytorin clinical trials.

Vytorin is a combination of the statin Zocor and the cholesterol-lowering drug Zetia.  Vytorin has been under the microscope since the ENHANCE study, which found the drug was ineffective in preventing clogged arteries, was released in January 2008.    Merck and Schering-Plough delayed releasing ENHANCE for more than a year – something critics have likened to fraud.  The delay prompted the House Energy and Commerce Committee to launch an investigation into the way Merck and Schering-Plough handled the ENHANCE findings.

Last March, the full ENHANCE study was vetted during the annual meeting of the American College of Cardiology (ACC). A panel of four doctors concluded that Vytorin should be used only as a last resort, considering that the expensive drug did not provide any added benefits. “Our strongest recommendation is that people need to go back to statins,” said panel member Dr. Harlan Krumhotz.

Then in July, Merck and Shearing-Plough released yet another Vytorin study, SEAS, which was designed to see if the drug helped people with aortic stenosis avoid heart attacks.  Not only did SEAS show that Vytorin offered no additional heart attack prevention, but Vytorin patients enrolled in the study had higher rates of cancer than those taking a placebo. In the trial 102 patients taking Vytorin developed cancer, compared with 67 taking the placebo. Of those, 39 people taking Vytorin died from their cancer, compared with 23 taking placebo. Researchers conducting the study said that while those numbers don’t prove a definitive cancer link, they were “statistically significant, meaning the odds were less than 5 percent that they were the result of chance.

Merck and Schering-Plough called the cancer findings an anomaly.  The companies based that claim on an analysis of the SEAS cancer findings that was conducted by Richard Peto, an Oxford University statistician.  But when SEAS was published in The New England Journal of Medicine, an accompanying editorial severely criticized Peto's conclusions.  The authors of the editorial wrote that a link to cancer deaths “should not be assumed to be a chance finding until further data are in", adding that doctors and patients “are unfortunately left for now with uncertainty about the safety and efficacy of the drug.”

According to today's Reuters report, Waxman is seeking documents regarding the monitoring boards that oversee patient safety in two other Vytorin clinical trials - known as Sharp and Improve It -  as part of his committee's ongoing investigation.   In September, the companies' lawyers said data for the two other trials should be released before the they conclude, and the boards for the two studies agreed to do so, Waxman's letter said.  

Statements from Merck and Schering-Plough said they would cooperate with Waxman's request.